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QCARD Can Improve Oncology Submissions

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Two Oncology Center of Excellence executives describe the benefits of the new QCARD initiative intended to improve study proposals...

Schumer Pushes Drug Shortage Legislation

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Senate majority leader Chuck Schumer says FDA must develop a plan to deal with drug shortages and Congress must pursue a legislati...

Wholesaling Prohibition Guidance

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FDA publishes a draft guidance about the prohibition on wholesaling of compounded drugs under Section 503B of the Federal Food, Dr...

Complete Response on Higher Dose Eylea

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FDA issues a complete response letter on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye dr...

UCBs Rystiggo Approved for Myasthenia Gravis

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FDA approves a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis in certain adult patients.

Implant Sales Rep Arrested in Fraud Case

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The U.S. government arrests former DePuy Synthes sales representative Matthew Capobianco on eight counts of wire fraud and one cou...

More ORA Changes Coming

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FDA announces additional changes in the way the Office of Regulatory Affairs operates.

FDA OKs Bayers Ultravist for Mammography

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FDA approves Bayers Ultravist (iopromide)-300 and Ultravist-370, iodine-based contrast agents for contrast-enhanced mammography.

FibroGen Quashes Pulmonary Fibrosis Trial

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FibroGen discontinues its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline dat...

Draft Guide on Medical Psychedelic Drugs

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Federal Register notice: FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.